Oxaliplatin, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, recurrent esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound Stage T2, N0 disease and beyond Bulk of tumor must be in the esophagus of patients with GE junction tumor Bronchoscopy is required if primary esophageal tumor is < 26 cm from the incisors No brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-1 Life expectancy At least 4 months Hematopoietic WBC ≥ 3,000/mm^3 Granulocyte count ≥ 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic Bilirubin normal ALT and AST ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Renal Not specified Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Pulmonary No clinically active interstitial lung disease Patients with chronic stable asymptomatic radiographic changes are eligible Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation No peripheral neuropathy ≥ grade II No severe hypersensitivity to gefitinib or any of its excipients No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy No active or ongoing infection No other uncontrolled illness No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent colony-stimulating factors during course 1 of study therapy Chemotherapy More than 4 weeks since prior chemotherapy Endocrine therapy Concurrent steroid therapy allowed Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 30 days since prior non-approved or investigational drugs No concurrent administration of any of the following: Phenytoin Carbamazepine Rifampin Barbiturates Highly-active antiretroviral therapy (HAART) Hypericum perforatum (St. John's wort) No other concurrent investigational agents or therapy
Sites / Locations
- Roswell Park Cancer Institute